Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There is no description of any material comprising a “linear tear pattern” as set forth in claim 16.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. In claim 1, line 3, “said surgical component” should be --the surgical component--, as while previously mentioned, the surgical component is not part of the claimed system, and only components of the system are “said”. See also line 5, where “said component” should be –the component--, and line 6, where “said anatomical space” should be –the anatomical space--. In line 4, “said perforation” lacks singular definition or is inconsistent with the previously defined “at least one perforation” of the same line.
In claim 2, line 2, “a plurality of shaped perforations” is indefinite, as it is unclear whether it further defines the previous defined “at least one perforation” or is a double recitation of the same, as the language is inconsistent.
In claim 4, line 2, “a plurality of perforations” is indefinite, as it is unclear whether it further defines the previous defined “at least one perforation” or is a double recitation of the same, as the language is inconsistent.
In claim 5, line 2, “a plurality of perforations” is indefinite, as it is unclear whether it further defines the previous defined “at least one perforation” or is a double recitation of the same, as the language is inconsistent.
In claim 7, line 1, “said perforations” lacks particularly plural definition or is inconsistent with the previously defined “at least one perforation” of claim 1, line 4.
In claim 17, line 2, “said component” should be --the component--, as while previously mentioned, the component is not part of the claimed system, and only components of the system are “said”. Similarly in line 3, “said anatomical space” should be --the anatomical space--.
In claim 19, lines 3 and 6, “said (surgical) component” should be --the (surgical) component--, as while previously mentioned, the surgical component is not part of the claimed system, and only components of the system are “said”. In lines 4 and 5 each, “said pouch” lacks antecedent basis.
In claim 21, line 4, “said anatomical space” should be --the anatomical space--.
In claim 23, line 2, “said surgical component” should be --the surgical component--.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 13, 17-19 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laub (10,729,414). Claims 1-2, 6, 19 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker (2019/0021713). Claims 1-2, 18-19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bell et al. (5,465,731). Each discloses an insertion system for use by a surgeon for placing a surgical component into an anatomical space comprising a pouch (600; 203; 260; respectively) having an open end (602; near 209; 264) for insertion of a surgical component (200 or 902; 209; specimen), the pouch having at least one perforation (612; 305; 265) along a portion thereof, the at least one perforation enabling the pouch to tear open for removal after (or once) the component is inserted in an anatomical space. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
As to claim 2, each discloses a plurality of perforations (612; defining 305; 265).
As to claim 3, Laub discloses the pouch may comprise a rectangular shape (see column 7, lines 1-14, bag 100 is disclosed as similar to bag 600).
As to claim 6, Laub and Walker each disclose the pouch may comprise a cylindrical shape (see column 7, lines 1-14, bag 100 is disclosed as similar to bag 600; see Figure 2).
As to claim 13, Laub discloses the pouch may comprise nylon (see column 7, lines 5-14).
As to claim 17, Laub further discloses an aperture (608) through which a component may be inserted for placement in use in an anatomical space.
As to claim 18, Laub and Bell et al. each discloses the pouch being generally frustoconical in shape.
As to claim 19, each container or pouch (600; 203; 260) is inherently sacrificial, not needing to be reused.
As to claim 22, Laub and Bell et al. each disclose the container or pouch is comprised of a polymer film (see column 7, lines 4-7; see column 4, lines 41-49).
As to claim 23, Laub and Walker each disclose the container or pouch shaped to accommodate a surgical component (900).
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Laub in view of Robinson (4,557,385). Laub discloses a pouch of a rectangular shape. Robinson discloses a rectangular pouch (10) including at least one or a plurality of perforations (15) extending along one (14) of the long sides of the rectangular pouch.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the rectangular pouch of Laub with perforations in four sides of the pouch in the manner of Robinson as claimed, as such a modification would predictably provide a complete tearing of the pouch.
Claims 8-9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Laub in view of Greenberg et al. (11,172,913). Laub discloses the pouch (100 or 600) being comprised of polyethylene or vinyl (see column 7, lines 5-14), but not particularly UHMW polyethylene or polyvinyl chloride. However, Greenberg et al. et al. disclose UHMW polyethylene and polyvinyl chloride (see column 12, lines 39-53) as materials employed to provide similar pouches. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch of Laub from UHMW polyethylene or polyvinyl chloride in the manner of Greenberg et al. as claimed, as such a modification would predictably provide a pouch of a known material. It has been held to be within the level of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as an obvious matter of design choice. See In re Leshin, 125 USPQ 416.
As to claim 9, the thickness of the pouch material may be provided as desired to render a better durability or easier tearing. It has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patently distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F. 2d 1338, 220 USPQ 777 (Fed. Cir. 1984) cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
As to claim 16, UHMW polyethylene is a material inherently having a linear tear pattern.
Claims 8-9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Laub in view of Huerta et al. (2009/0116768). Laub discloses the pouch (100 or 600) being comprised of polyethylene or vinyl (see column 7, lines 5-14), but not particularly UHMW polyethylene or polyvinyl chloride. However, Huerta et al. disclose UHMW polyethylene (see paragraphs 015 and 0152) as a material employed to provide similar pouches. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch of Laub from UHMW polyethylene in the manner of Huerta et al. as claimed, as such a modification would predictably provide a pouch of a known material. It has been held to be within the level of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as an obvious matter of design choice. See In re Leshin, 125 USPQ 416.
As to claim 9, the thickness of the pouch material may be provided as desired to render a better durability or easier tearing. It has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patently distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F. 2d 1338, 220 USPQ 777 (Fed. Cir. 1984) cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
As to claim 16, Huerta et al. further disclose UHMW polyethylene provides a linear tear property (see paragraph 0152).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Laub in view of Menn et al. (8,579,914). Laub discloses the pouch (100 or 600) being comprised of various plastics, but not particularly polytetrafluoroethylene. However, Menn et al. disclose polytetrafluoroethylene as a material known to be advantageously employed in similar pouches (see column 5, line 57 through column 6, line 16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch of Laub from polytetrafluoroethylene in the manner of Menn et al. as claimed, as such a modification would predictably provide a pouch having a recognized slippery property.
As to claim 11, the thickness of the pouch material may be provided as desired to render a better durability or easier tearing. It has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patently distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F. 2d 1338, 220 USPQ 777 (Fed. Cir. 1984) cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the art as applied to claim 10 above, and further in view of Craig et al. (2015/0088127). The previous art does not disclose the pouch to have an exterior of a textured surface portion to enhance gripping. However, Craig et al. disclose a similar pouch (90,190) which has an exterior of a textured surface portion to enhance gripping (see paragraph 0089). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch of the previous combination with an exterior of a textured surface portion to enhance gripping in the manner of Craig et al. as claimed, as such a modification would predictably provide enhanced gripping to facilitate operation of the system.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Laub in view of Johnson et al. (5,167,650). Laub discloses the pouch (100 or 600) being comprised of various waterproofed plastics (see column 7, lines 5-17), but not particularly employing fluorinated ethylene propylene. However, Johnson et al. disclose fluorinated ethylene propylene as a material known to be advantageously employed in similar pouches (see column 5, lines 54-57) as a waterproofing agent. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch of Laub with fluorinated ethylene propylene in the manner of Johnson et al. as claimed, as such a modification would predictably provide a pouch having an improved waterproof property.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over the art as applied to claim 19 above, and further in view of Craig et al. (2015/0088127). The previous art does not disclose the pouch to have an exterior of a textured surface portion to enhance gripping. However, Craig et al. disclose a similar pouch (90,190) which has an exterior of a textured surface portion to enhance gripping (see paragraph 0089). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch or container of either one of Laub and Bell et al. with an exterior of a textured surface portion to enhance gripping in the manner of Craig et al. as claimed, as such a modification would predictably provide enhanced gripping to facilitate operation of the system.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the art as applied to claim 20 above, and further in view of Dais et al. (11,691,790). The previous art does not disclose the textured surface to be comprised of raised elements. However, Dais et al. disclose raised elements provide a textured surface for improving gripping in a pouch portion (see column 16, line 19 through column 18, line 8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the pouch or container of either one of Laub and Bell et al. with an exterior of a textured surface portion comprising raised elements to enhance gripping in the manner of Dais et al. as claimed, as such a modification would predictably provide enhanced gripping to facilitate operation of the system.
Claims 5 and 7 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Prior Art not relied upon: Please refer to the additional references listed on the attached PTO-892, which, while not relied upon for the claim rejection, these references are deemed relevant to the claimed invention as a whole.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYON P GEHMAN whose telephone number is (571) 272-4555. The examiner can normally be reached on Tuesday through Thursday from 7:30 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Orlando Aviles, can be reached on (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRYON P GEHMAN/Primary Examiner, Art Unit 3736 BPG
Bryon P. Gehman
Primary Examiner
Art Unit 3736